Biomanufacturing

High-standard, flexible and compliant manufacturing, integrated into our existing discovery pipeline or offered as a modular service.

Biologics Manufacturing

Immune Biosolutions is a Contract Development and Manufacturing Organization (CDMO) with a state-of-the-art GMP and non-GMP manufacturing facility for antibody and recombinant protein production. We offer protein expression and purification services including all upstream (USP) and downstream (DSP) processes necessary to bring a protein compound of interest to pre-clinical and clinical studies. All of our biomanufacturing services are performed in a clean room compliant with ISO 7 and ISO 5 standards.

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CHO Cell Banking

Clonal selection

Stable pools

RCB (Research Cell Bank)

MCB (Master Cell Bank)

WCB (Working Cell Bank)

Upstream Processes – USP

Cell cultivation in shake flasks, up to 2L

25L Cytiva Wave 25/50® bioreactor

50L Eppendorf BioFlo 120® bioreactor

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Downstream Processes – DSP

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Protein Purification

  • Affinity chromatography (Protein A/G/L, custom immunoaffinity)
  • Size exclusion chromatography (SEC)
  • Ion-exchange chromatography (CEX, AEX)
  • Multi-column sequential chromatography

FPLC

  • ÄKTA Avant 150
  • Bio-Rad NGC

Tangential Flow (TFF) and Viral Filtration

  • ÄKTA Flux S
  • ÄKTA Flux 6
  • Kross Flow
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Analytics

Bulk properties (appearance, conductivity, pH, osmolality)

Identity (defined by customer)

Purity (aggregation, charge variants, size variants, impurity)

Concentration

Potency (target binding, cell-based assays)

Safety (endotoxins, HCP, DNA, sterility)

Stability

  • Long-term stability studies at 4°C
  • Accelerated stability studies at 25°C
  • Freeze/thaw stability studies
  • Temperature and humidity mapping to ensure uniformity within the storage area
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Quality Management System (QMS)

Immune Biosolutions operates under a structured Quality Management System aligned with current Good Manufacturing Practices and designed to be Annex 1–ready. Our framework includes controlled documentation, change management, deviation and CAPA systems, equipment qualification, environmental monitoring, and personnel training programs. Defined gowning, cleaning, and aseptic processing procedures support reliable, compliant manufacturing of high-quality biologics.

  • SOP
  • MBR
  • Certificate of analysis for drug substances and drug products
  • Release documents

Case Study

  • Cell Line development for clinical trials
  • Biomanufacturing (6 clinical lots) for the Clinical Trial Phase I & II of IBIO123
  • Manufacturing of 3 lots of a recombinant protein for a client, which was approved by Health Canada for clinical studies
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